Bioequivalence and Bioavailability Forum

Hi Olivbood,

❝ The guideline specifies that "At a minimum, 12 subjects should be enrolled in each treatment arm." I deduce from it that this is the minimal sample size considering a parallel design study.

Correct.

❝ Alternatively, for a classic 2x2 cross-over study the minimal sample size should be 12 subjects in total since each subject will experience both fed and fasted status.

❝

❝ Is my understanding correct?

Correct, again.

I both cases I would include a bit more subjects to be protected against eventual dropouts. I guess the FDA wouldn’t be amused to get a study in 11 subjects although the guidance clearly states “12 enrolled”.